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The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
The OlympiA trial will conduct its primary analysis early, after the Independent Data Monitoring Committee found it met its primary endpoint in BRCA mutated early breast cancer patients.
The Emergency Use Listing will allow doses of the COVID-19 vaccines to be distributed through COVAX, the WHO’s vaccine allocation facility.
Pfizer and BioNTech have agreed to supply the European Union with 200 million additional doses of COMIRNATY in 2021, making the total 500 million doses.
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
The UK has conditionally approved Enhertu® (trastuzumab deruxtecan) as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer based on Phase II trial results.
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-300x278.jpg)
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-e1613474706496.jpg)
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
Studies suggest there are better treatment options than sunitinib for kidney cancers; cabozantinib in metastatic papillary kidney cancer and lenvatinib/pembrolizumab for renal cell carcinoma.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
Co-injecting doxorubicin with LATTE, a novel ionic liquid formulation, resulted in uniform chemotherapy delivery and successful ablation in solid tumours.
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine-300x278.jpg)
![Male Thai child receiving oral polio vaccine from healthcare worker [Credit: frank60 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Oral-vaccine.jpg)
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
The approval makes Ogluo™ Europe’s first ready-to-use liquid glucagon for rescuing diabetic patients from severe hypoglycaemic events.
Research suggests at least a fifth of the US population are resistant to receiving a COVID-19 vaccine, reports suggest this could be due to disinformation and safety concerns.
